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ClinicalTrials.gov ID

NCT07665372

Lead Sponsor

Johns Hopkins UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

80Estimated

Last Update Posted

Jun 26, 2026Actual

Start Date

Sep 2026Estimated

Primary Completion Date

Aug 2030Estimated

Completion Date

Aug 2031Estimated

Official Title

HOPE in Action Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes

Brief Summary

This research is being done to better understand opportunistic infections and cancer in transplant recipients with HIV who receive livers from a donor with HIV compared to livers from donors without HIV.

Detailed Description

Previously, people with HIV in need of a transplant could only receive organs from a donor without HIV. However, in November 2013, the HIV Organ Policy Equity (HOPE) Act made it possible for people with HIV to receive organs from donors with HIV as a part of a research study.

Over the last two decades, people with HIV have received organs from donors without HIV, and in general, these recipients have done well after transplant and still maintained control of HIV. Over the last several years, people with HIV have received organs from donors with HIV, and in general, these recipients have also done well after transplant and still maintained control of HIV. Although organ transplant into people with HIV using donors with and without HIV has been successful, the use of organs from donors with HIV may increase the risk of certain opportunistic infections and cancer in some people. Opportunistic infections are when pathogens (germs) cause infections in people with weakened immune systems that would not happen, or would be mild, in people with healthy immune systems. This study will look to better understand opportunistic infections and cancer in transplant recipients with HIV (HIV R+) who receive livers from donors with HIV (HIVD+) or without HIV (HIV D-).

• HIV

• HIV D+/R+
• HIV D-/R+

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Participant meets local criteria for liver or simultaneous liver kidney (SLK) transplant.
• Participant or legally authorized representative (in accordance with Johns Hopkins Medicine Institutional Review Board (IRB) and local IRB policy) is able to understand and provide informed consent.
• Participant has documented HIV infection by any licensed assay or documented history of detectable HIV-1 RNA.
• Participant is ≥ 18 years old.
• Most recent HIV-1 RNA < 50 copies RNA/mL. Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements > 200 copies/mL. Organ recipients who are unable to tolerate Antiretroviral Therapy (ART) due to organ failure or recently started ART may be eligible despite a detectable viral load if safe and effective ART to be used by the recipient after transplantation is described.

Exclusion Criteria:

• Participant has prior progressive multifocal leukoencephalopathy (PML), cryptosporidiosis of > 1 month duration, or prior primary Central Nervous System (CNS) lymphoma.
• Participant is pregnant or breastfeeding.
• Past or current medical problems or findings from medical history, physical examination, or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Primary Purpose

Treatment

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Johns Hopkins UniversityOTHER

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)NIH

william.henry.kitchens.jr@emory.edu